Self-Expanding Peripheral Stent System


Product Overview

Self
EverFlex - PRB35-07-020-120


Device Description

A non-bioabsorbable tubular device intended to be implanted in a peripheral artery (excludes aorta, coronary, and intracranial arteries) to indefinitely maintain patency and improve luminal diameter in patients with atherosclerotic disease, or following the recanalization of a total occlusion. It may additionally be intended to be implanted in an obstructed biliary duct; it is not dedicated to carotid artery implantation. The stent is made entirely of metal [e.g., nickel-titanium alloy (Nitinol) mesh structure] and is typically implanted by a dedicated instrument where it self-expands upon release or is balloon expanded.


Environmental Conditions

  • Special Storage Condition, Specify
    • Keep dry

  • Device Sizes

  • Length: 20 Millimeter
  • Outer Diameter: 7 Millimeter
  • Catheter Gauge: 6 French
  • Working Length,120,Centimeter;Compatible Guidewire,.035,Inch;Lumen Diameter,5.5 to 6.5,Millimeter;
  • Outer Diameter: 2 Millimeter
    • Length: 20 Millimeter
    • Outer Diameter: 7 Millimeter
    • Catheter Gauge: 6 French
    • Working Length,120,Centimeter;Compatible Guidewire,.035,Inch;Lumen Diameter,5.5 to 6.5,Millimeter;
    • Outer Diameter: 2 Millimeter


    Device Sterilization

    Device Sterile: True

    Sterilization Prior To Use: False

    Sterilization Methods: No Data Available


    Product Codes

    Code: NIP

    Device Name: Stent, Superficial Femoral Artery

    Device Class: 3

    Physical State: N/A

    Definition: Stent, Superficial Femoral Artery -- a metal scaffold placed via a delivery catheter into the superficial femoral artery artery to maintain the lumen

    Submission Type ID: 2

    Review Panel: CV

    Review Code: N/A

    Technical Method: N

    Gmp Exempt Flag: N/A

    Life Sustain Support Flag: Y

    Unclassified Reason: N/A

    Implant Flag: Y

    Target Area: N/A

    Regulation Number: N/A

    Third Party Flag: N

    Medical Specialty: N/A


    Device Identifiers

    Device Id: 00821684034255

    Device Type: Primary

    DeviceId Issuing Agency: GS1

    Contains DI Number: N/A

    Package Quantity: N/A

    Package Discontinue Date: N/A

    Package Status: N/A

    Package Type: N/A


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